Identity
- Trade Name
- Beaver Visitec Inter FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Non Reinforced Gown_Two Hand Towels_35 gsm SMS w/AS_XL_Non-Sterile_676ea/cs FDA UDI
- Model / Reference
- 8008625-HB FDA UDI
- Description
- Non Reinforced Gown_Two Hand Towels_35 gsm SMS w/AS_XL_Non-Sterile_676ea/cs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16931918170688 FDA UDI
- 510(k) Number
- K102652 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical gown, single-use
Beaver Visitec Inter by GRI Medical & Electronic Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical gown, single-use.
- Halyard — O&M HALYARD, INC. · Class II
- Yellow gown with elastics (length 120 cm) — Omnia Spa · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- T7 — Stryker Corp. · Class II
- StringKing — String King Lacrosse, LLC · Class II
Cleared under the same submission
K102652 also covers:
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- BVI — GRI Medical & Electronic Technology Co., Ltd.
- BVI — GRI Medical & Electronic Technology Co., Ltd.
- HALYARD — GRI Medical & Electronic Technology Co., Ltd.
- HALYARD — GRI Medical & Electronic Technology Co., Ltd.
- HALYARD — GRI Medical & Electronic Technology Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GRI Medical & Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI 2e664606-d575-4d4a-b646-3b3227ecbc68 35 fields · synced Sep 18, 2026